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The purpose of this study is to determine if KRX-0502 (ferric citrate) is a safe and effective treatment for the management of serum phosphorus levels and iron deficiency in anemic chronic kidney disease (CKD) subjects not on dialysis. Total length of treatment is approximately 12 weeks.

Change in TSAT (transferrin saturation) from baseline to end of treatment [ Time Frame: 12 Weeks ]

Change in serum phosphorus levels from baseline to end of treatment [ Time Frame: 12 Weeks ]

Secondary Outcome Measures:

Rates of adverse events overall and by organ system class, preferred term, severity, and suspected relationship to study drug by treatment assignment as a measure of safety and tolerability [ Time Frame: Approximately 16 weeks ]

SAEs will be monitored for an additional 28 days after last study visit.

Type of concomitant medications used by treatment assignment as a measure of safety [ Time Frame: Approximately 16 weeks ]

Change in sequential blood chemistries by treatment assignment as a measure of safety [ Time Frame: 12 Weeks ]

Change in hemoglobin levels from baseline to end of treatment by treatment assignment as a measure of safety [ Time Frame: 12 Weeks ]

Change in ferritin levels from baseline to end of treatment [ Time Frame: 12 Weeks ]

Placebo will be taken with or within one hour of meals or snacks. The number of placebo pills will depend on the patient's serum phosphorus results at each treatment visit.

Drug: Placebo

Detailed Description:

This is a randomized, double-blind, placebo-controlled, three-period, multi-center clinical trial. Following a Screening and Qualification Period and a two-week Washout Period (for those subjects entering the study on a phosphate binder), eligible subjects will be randomized in a 1:1 ratio to receive either KRX-0502 (ferric citrate) or placebo for up to approximately 12 weeks. The purpose of this study is to determine if KRX-0502 (ferric citrate) is a safe and effective treatment for the management of serum phosphorus levels and iron deficiency in anemic CKD subjects not on dialysis.

Eligibility

Information from the National Library of Medicine

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